Controlled Environments - July/August 2014

manufacturing capacity and capability, market concentration, or just-in-time inventory practices that result in minimal product inventory being on hand at any given time. Manufacturers could consider opportunities for building redundant manufacturing capacity, holding spare capacity, or increasing inventory levels to lower the risks of shortages. Other stakeholders might explore how to incentivize such practices.

Price escalation in the face of drug shortages exacerbates
the problem. The FDA is asking key stakeholders to explore
mitigation activities to minimize gray market activities.

The agency has taken positive steps to address the drug short-
ages issue. Notification to the FDA by drug manufacturers of
potential supply disruptions has increased six-fold since the pres-
idential directive. Now, status of drug shortages can be found on
the FDA’s website and is searchable alphabetically. It remains to be
seen how earnest industry will be in addressing these issues given
the public’s quality blind spot. The public assumes our drugs are
safe and effective regardless of any data to the contrary. The agen-
cy is in a difficult position to send a consistent quality message
to the industry when it has to deal with potential drug shortage
considerations, on a case-by-case basis. However, the strategic
plan by FDA is a solid step toward establishing systems that will, if
nothing else, provide an early warning so a potential remediation
may be identified to avoid the shortage.

References

1. USGAO - http://www.gao.gov/assets/590/586979.pdf
2. FDASIA - http://www.gpo.gov/fdsys/pkg/BILLS-
112s3187enr/pdf/BILLS-112s3187enr.pdf
3. Presidential Executive Order 13588, 13589
4. FDA’s Strategic Plan for Preventing and Mitigating Drug
Shortages, October 2013 - http://www.fda.gov/downloads/
drugs/drugsafety/drugshortages/ucm372566.pdf

Bikash Chatterjee, President and CTO, Pharmatech Associates, has been involved in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for over 30 years. His expertise includes site selection, project management, design, and validation of facilities for U.S. and European regulatory requirements.